The Dose-Response Effects of Lean Beef in a Mediterranean-Style Dietary Pattern on Cardiovascular Disease Risk Factors

NCT02723617 | Completed

• 1 other identifier: HS54
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this study is to evaluate the effects of different quantities of lean beef (0.5, 2.5, 5.5 oz/day) on lipids, lipoproteins, and vascular health endpoints in the context of a modified Mediterranean dietary pattern that is representative of foods typically consumed in the United States.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Lipid/lipoprotein profile will be measured in blood

  The following will be measured in the blood on 2 consecutive days at baseline (start of trial) and the end of each 4-week diet period: lipids and lipoproteins, apolipoproteins, lipoprotein particle number/size, and proprotein convertase subtilisin/kexin type 9 (PCSK9).

  Week 0, end of diet period 1 (week 4), end of diet period 2 (week 9), end of diet period 3 (week 15), end of diet period 4 (week 21)

Secondary Outcomes (6)

• Pulse Wave will be measured using Sphygmocor EXCEL

  Week 0, end of diet period 1 (week 4), end of diet period 2 (week 9), end of diet period 3 (week 15), end of diet period 4 (week 21)

• Markers of vascular health will be measured in blood

  Week 0, end of diet period 1 (week 4), end of diet period 2 (week 9), end of diet period 3 (week 15), end of diet period 4 (week 21)

• Systemic inflammation will be measured in blood

  Week 0, end of diet period 1 (week 4), end of diet period 2 (week 9), end of diet period 3 (week 15), end of diet period 4 (week 21)

• Fecal microbiota will be analyzed

  Week 0, end of diet period 1 (week 4), end of diet period 2 (week 9), end of diet period 3 (week 15), end of diet period 4 (week 21)

• Measures of oxidative stress will be measured in urine

  Week 0, end of diet period 1 (week 4), end of diet period 2 (week 9), end of diet period 3 (week 15), end of diet period 4 (week 21)

Study Arms (4)

MED 0.5

OTHER

Other: MED 0.5

MED 2.5

OTHER

Other: MED 2.5

MED 5.5

OTHER

Other: MED 5.5

AAD 2.5

OTHER

Other: AAD 2.5

Interventions

MED 0.5 OTHER

Participants will be fed a Mediterranean diet providing 0.5 oz. per day of lean beef.

MED 0.5

MED 2.5 OTHER

Participants will be fed a Mediterranean diet providing 2.5 oz. per day of lean beef.

MED 2.5

MED 5.5 OTHER

Participants will be fed a Mediterranean diet providing 5.5 oz. per day of lean beef.

MED 5.5

AAD 2.5 OTHER

Participants will be fed an average American diet providing 2.5 oz. per day of lean beef.

AAD 2.5

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body Mass Index between 20 and 40 kg/m2
• Non-smoker
• Fasting glucose ≤ 126 mg/dl

You may not qualify if:

• Low HDL-C (\<15th percentile of US population)
• Use of cholesterol lowering medications
• Elevated blood pressure (systolic blood pressure \> 160 mm Hg and diastolic blood pressure \> 100 mm Hg) or use of medication to treat hypertension for less than 6 months
• Elevated triglycerides ( \> 350 mg/dL)
• Active cardiovascular disease (such as a heart attack or procedure within the past six months or participation in a cardiac rehabilitation program within the last six months, stroke, or history/treatment for transient ischemic attacks in the past six months, or documented history of pulmonary embolus in the past six months)
• Presence of kidney disease, liver disease, gout, untreated or unstable hyper- or hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
• Women who have given birth during the previous 12 months
• Pregnant women or women who plan to become pregnant or become pregnant during the study
• Lactating women
• Weight loss of ≥ 10% of body weight within 6 months prior to enrolling in the study
• Smokers or use of any tobacco products in past 6 months
• Known (self-reported) allergy or adverse reaction to study foods
• History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
• Unable or unwilling to give informed consent or communicate with study staff
• Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol

Sponsors & Collaborators

• USDA Beltsville Human Nutrition Research Center: lead
• Penn State University: collaborator

Study Sites (2)

USDA-ARS, Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

Penn State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (3)

• DiMattia ZS, Zhao J, Hao F, Koshkin S, Bisanz JE, Patterson AD, Fleming JA, Kris-Etherton PM, Petersen KS. Effect of Varying Quantities of Lean Beef as Part of a Mediterranean-Style Dietary Pattern on Gut Microbiota and Plasma, Fecal, and Urinary Metabolites: A Randomized Crossover Controlled Feeding Trial. J Am Heart Assoc. 2025 Oct 7;14(19):e041063. doi: 10.1161/JAHA.125.041063. Epub 2025 Sep 19.

  PMID: 40970516 DERIVED

• Fleming JA, Petersen KS, Kris-Etherton PM, Baer DJ. A Mediterranean-Style Diet with Lean Beef Lowers Blood Pressure and Improves Vascular Function: Secondary Outcomes from a Randomized Crossover Trial. Curr Dev Nutr. 2025 Feb 22;9(4):104573. doi: 10.1016/j.cdnut.2025.104573. eCollection 2025 Apr.

  PMID: 40201153 DERIVED

• Fleming JA, Kris-Etherton PM, Petersen KS, Baer DJ. Effect of varying quantities of lean beef as part of a Mediterranean-style dietary pattern on lipids and lipoproteins: a randomized crossover controlled feeding trial. Am J Clin Nutr. 2021 May 8;113(5):1126-1136. doi: 10.1093/ajcn/nqaa375.

  PMID: 33826691 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Supervisory Research Physiologist

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: March 30, 2016
• Study Start: April 25, 2016
• Primary Completion: May 16, 2018
• Study Completion: May 16, 2018
• Last Updated: May 1, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)